Detection of anti-ESA antibodies in human samples from PRCA and non-PRCA patients: An immunoassay platform comparison

Nephrology Dialysis Transplantation

Volumn 27, Issue 2, 2012, Pages 688-693

  Barger, Troy E ^a   Kuck, Andrew J ^a   Chirmule, Narendra ^a   Swanson, Steven J ^a   Mytych, Daniel T ^a  

^a AMGEN INC   (United States)

Author keywords

Biacore; ELISA; erythropoietin; PRCA; RIP

Indexed keywords

ERYTHROPOIETIN ANTIBODY; IMMUNOGLOBULIN G ANTIBODY; IMMUNOGLOBULIN M ANTIBODY; NEUTRALIZING ANTIBODY;

ANTIBODY AFFINITY; ANTIBODY DETECTION; ANTIBODY SPECIFICITY; ANTIBODY STRUCTURE; ARTICLE; BLOOD SAMPLING; CHEMOLUMINESCENCE; CONCENTRATION (PARAMETERS); CONTROLLED STUDY; CORRELATION ANALYSIS; DIAGNOSTIC ACCURACY; ELECTROCHEMILUMINESCENCE BRIDGING ENZYME LINKED IMMUNOSORBENT ASSAY; HUMAN; HUMAN CELL; IMMUNE RESPONSE; IMMUNOASSAY; INTERMETHOD COMPARISON; PRIORITY JOURNAL; PURE RED CELL ANEMIA; RADIOIMMUNOPRECIPITATION; SENSITIVITY AND SPECIFICITY; SURFACE PLASMON RESONANCE; VALIDATION PROCESS;

ANTIBODIES, ANTI-IDIOTYPIC; CASE-CONTROL STUDIES; ENZYME-LINKED IMMUNOSORBENT ASSAY; FEMALE; HEMATINICS; HUMANS; IMMUNOASSAY; MALE; RADIOIMMUNOPRECIPITATION ASSAY; RED-CELL APLASIA, PURE; REPRODUCIBILITY OF RESULTS; SAMPLING STUDIES; SENSITIVITY AND SPECIFICITY; SURFACE PLASMON RESONANCE;

EID: 84856879485     PISSN: 09310509     EISSN: 14602385     Source Type: Journal    
DOI: 10.1093/ndt/gfr213     Document Type: Article

References (20)

1. Ammus S, Yunis A. Acquired pure red cell aplasia. Am J Hematol 1987; 24: 311-326
2. Hoesel W, Gross J, Moller R et al. Development and evaluation of a new ELISA for the detection and quantification of antierythropoietin antibodies in human sera. J Immunol Methods 2004; 294: 101-110
3. Tacey R, Greway A, Smiell J et al. The detection of anti-erythropoietin antibodies in human serum and plasma: Part I. Validation of the protocol for a radioimmunoprecipitation assay. J Immunol Methods 2003; 283: 317-329
4. Mytych D, La S, Barger T et al. The development and validation of a sensitive, dual-flow cell, SPR-based biosensor immunoassay for the detection, semi-quantitation, and characterization of antibodies to darbepoetin alfa and Epoetin alfa in human serum. J Pharm Biomed Anal 2009; 49: 415-426
5. Wadhwa A, Bird C, Dilger P et al. Strategies for detection, measurement and characterization of unwanted antibodies induced by therapeutic biologicals. J Immunol Methods 2003; 278: 1-17
6. Mire-Sluis A, Gaines Das R, Lernmark A. Standardization of antibody preparations for use in immunogenicity studies: a case study using the World Health Organization International Collaborative Study for Islet Cell Antibodies. Dev Biol (Basel) 2003; 112: 153-163
7. Mire-Sluis AR, Barrett YC, Viswanath D et al. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J Immunol Methods 2004; 289: 1-16
8. Wei X, Swanson S, Gupta S. Development and validation of a cellbased bioassay for the detection of neutralizing antibodies against recombinant human erythropoietin in clinical studies. J Immunol Methods 2004; 293: 115-126
9. Pollock C, Johnson D, Hörl W et al. Pure red cell aplasia induced by erythropoiesis-stimulating agents. Clin J Am Soc Nephrol 2008; 3: 193-199
10. Boven K, Stryker S, Knight J et al. The increased incidence of pure red cell aplasia with an Eprex formulation in uncoated rubber stopper syringes. Kidney Int 2005; 67: 2346-2353
11. Casadevall N, Rossert J. Importance of biologic follow-ons: experience with EPO. Best Pract Res Clin Haematol 2005; 18: 381-387
12. Safety Study for Subcutaneous Epoetin Alfa Biosimilar Binocrit/Epoetin Alfa Hexal/Abseamed Suspended. posted 07/10/2009. Generics and Biosimilars Initiative; 2009. http://www.gabionline. net/Biosimilars/News/Safety-study-for- subcutaneous-epoetin-alfa-biosimilar-Binocrit-Epoetin-alfa-Hexal-Abseamed- suspended
13. Keithi-Reddy S, Kandasamy S, Singh A. Pure red cell aplasia due to follow-on epoetin. Kidney Int 2008; 74: 1617-1622
14. Thorpe R, Swanson S. Assays for detecting and diagnosing antibody-mediated pure red cell aplasia (PRCA): an assessment of available procedures. Nephrol Dial Transplant 2005; 20 (Suppl 4): iv16-iv22
15. Thorpe R, Swanson S. Current methods for detecting antibodies against erythropoietin and other recombinant Proteins. Clin Diagn Lab Immunol 2005; 12: 28-39
16. Swanson S, Ferbas J, Mayeux P et al. Evaluation of methods to detect and characterize antibodies against recombinant human erythropoietin. Nephron Clin Pract 2004; 96: c88-c95
17. Gross J, Moller R, Bischoff S et al. Detection and characterization of antibodies against recombinant erythropoietin human erythropoietin by RIPA, ELISA and neutralization assay in patients with renal anemia. J Immunol Methods 2008; 336: 152-158
18. Wu G, Wadgymar A, Wong G et al. A cross-sectional immunosurveillance study of anti-EPO antibody levels in CRF patients receiving epoetin alfa in 5 Ontario renal centers. Am J Kidney Dis 2004; 44: 264-269
19. Swanson SJ. Detection of Baseline Anti-erythropoietin Antibodies in Patients with Chronic Kidney Disease, Using the BIAcore Immunoassay. Paper presented at the European Renal Association-European Dialysis Transplant Association, Lisbon, Portugal, May 17, 2004
20. Proceedings of the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use: Tripartite guideline, S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals, 1997. http://www.ich.org/fileadmin/Public-Web-Site/ICH- Products/Guidelines/Safety/S6-R1/Step4/S6-Guideline.pdf